Smith Amish Joint Ease Cream (4oz) - 72609-045-04

Smith Amish Joint Ease Cream (4oz) - 72609-045-04
SPL v4
SPL
SPL Set ID 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8
Route
TOPICAL
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Almond Oil Jojoba Oil Glyceryl Monostearate Peppermint Oil .alpha.-tocopherol Arnica Montana Whole Cetyl Palmitate Sodium Citrate Stearic Acid Tea Tree Oil Water Rosemary Oil Eucalyptus Oil Glycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-28

Description

Menthol 1.25%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 1.25%

Uses

For the termporary relief of minor aches and pains of muscles and joints associated with arthritis.

Label

Smith Amish Joint Ease Cream (72609-045-04)

Deep Penetrating & Soothing

Gently targets joint & tendon discomfort

Net wt. 4oz (114g)

Section 42229-5

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Section 50566-9
  • If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not bandage tightly.
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only

Avoid contact with eyes

Directions

Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Drug Facts

Menthol 1.25%

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

Other Information

Protect from excessive heat

Store at 20-25 oC (68-77F)

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the termporary relief of minor aches and pains of muscles and joints associated with arthritis.

Label

Smith Amish Joint Ease Cream (72609-045-04)

Deep Penetrating & Soothing

Gently targets joint & tendon discomfort

Net wt. 4oz (114g)

Section 42229-5 (42229-5)

Tamper evident: Do not use if safety seal under cap is broken or missing.

Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

Section 50566-9 (50566-9)
  • If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not bandage tightly.
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical analgesic

Warnings

For external use only

Avoid contact with eyes

Directions

Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Drug Facts

Menthol 1.25%

Questions?

Call (866) 419-3567

Monday through Friday 8:00am - 2:00pm ET

Other Information (Other information)

Protect from excessive heat

Store at 20-25 oC (68-77F)

Inactive Ingredients

Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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